Heart valve prostheses including torque anchoring mechanisms and delivery devices for the heart valve prostheses

ABSTRACT

A delivery device for delivery and deployment of a heart valve prosthesis with a torque anchoring mechanism includes a balloon having a shaped surface configured to engage a corresponding shaped surface of the heart valve prosthesis. The balloon is configured to rotate about a central longitudinal axis of the delivery device to rotate the heart valve prosthesis.

FIELD OF THE INVENTION

The present invention relates to systems and methods for percutaneousimplantation of a heart valve prosthesis. More particularly, it relatesto the systems and methods for anchoring a stented prosthetic heartvalve via transcatheter implantation.

BACKGROUND

Heart valves are sometimes damaged by disease or by aging, resulting inproblems with the proper functioning of the valve. Heart valvereplacement via surgical procedure is often used for patients sufferingfrom valve dysfunctions. Traditional open surgery inflicts significantpatient trauma and discomfort, requires extensive recuperation times,and may result in life-threatening complications.

To address these concerns, efforts have been made to perform cardiacvalve replacements using minimally invasive techniques. In thesemethods, laparoscopic instruments are employed to make small openingsthrough the patient's ribs to provide access to the heart. Whileconsiderable effort has been devoted to such techniques, widespreadacceptance has been limited by the clinician's ability to access onlycertain regions of the heart using laparoscopic instruments.

Still other efforts have been focused upon percutaneous transcatheter(or transluminal) delivery of replacement cardiac valves to solve theproblems presented by traditional open surgery and minimally invasivesurgical methods. In such methods, a heart valve prosthesis is compactedfor delivery in a delivery device, also known as a delivery catheter andthen advanced, for example through an opening in the native vasculature,and through to the heart, where the heart valve prosthesis is thendeployed in the valve annulus (e.g., the mitral valve annulus).

Various types and configurations of heart valve prostheses are availablefor percutaneous valve replacement procedures. In general, heart valveprosthetic designs attempt to replicate the function of the valve beingreplaced and thus will include valve leaflet-like structures. Heartvalve prostheses are generally formed by attaching a bioprosthetic valveto a frame made of a wire or a network of wires. Such heart valveprostheses can be contracted radially to introduce the heart valveprosthesis into the body of the patient percutaneously through adelivery device (catheter). The heart valve prosthesis can be deployedby radially expanding it once positioned at the desired target site.

It is important the heart valve prostheses are properly anchored at thedesired implantation site. In some situations, for example and not byway of limitation, the native mitral valve, it may be difficult toproperly anchor the heart valve prosthesis. This may lead to unwantedmigration of the heart valve prosthesis and/or paravalvular leakage(PVL).

Accordingly, there is a need for improved anchoring mechanisms for heartvalve prostheses and methods to more securely anchor heart valveprostheses implanted via transcatheter delivery devices.

SUMMARY OF THE INVENTION

Embodiments hereof relate to a delivery device for delivery anddeployment of a heart valve prosthesis with a torque anchoring mechanismto the site of a damaged or diseased native valve. The delivery deviceincludes a balloon having a first uninflated configuration and a secondinflated configuration. The balloon includes a shaped end that isconfigured to engage a corresponding shaped end of the heart valveprosthesis, and is configured to rotate about a central longitudinalaxis of the delivery device. The balloon is configured to rotate thecorresponding shaped end of the heart valve prosthesis.

Embodiments hereof also relate to a delivery device for delivery anddeployment of a heart valve prosthesis to the site of a damaged ordiseased native valve. The delivery device includes an inner shaftcoupled to a handle and a tether shaft disposed above the inner shaft.The tether shaft includes a proximal shaft portion and a plurality oftethers extending from a distal portion of the proximal shaft portion.The tethers are configured to engage the proximal shaft portion of thetether shaft to the end of the heart valve prosthesis. The tether shaftis rotatable about the inner shaft and configured to correspondinglyrotate the tethers and at least a portion of the heart valve prosthesis.

Embodiments hereof also relate to a method for deploying and anchoring aheart valve prosthesis with a torque anchoring mechanism at a desiredimplantation site. The method includes delivering the heart valveincluding the torque anchoring mechanism in a radially compressedconfiguration, in a delivery device to the desired implantation site.The heart valve prosthesis is expanded at the desired location to aradially expanded configuration. The delivery device is rotated,rotating at least a portion of the heart valve prosthesis and embeddingthe torque anchoring mechanism into tissue at the desire implantationsite.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective illustration of an embodiment of a heart valveprosthesis with a torque anchoring mechanism according to an embodimenthereof.

FIG. 2 is a side view illustration of an embodiment of a delivery deviceaccording to an embodiment hereof.

FIG. 3 is an exploded perspective illustration of the delivery device ofFIG. 2.

FIG. 4 is a side cutaway illustration of the delivery device of FIG. 2.

FIG. 5 is a cross section illustration of the delivery device of FIG. 2taken along line 5-5 of FIG. 4.

FIG. 6A a side cutaway illustration of the delivery device of FIG. 2 ina delivery configuration.

FIG. 6B is a side cutaway illustration of the delivery device of FIG. 2with the capsule retracted and the balloon in an inflated configuration.

FIG. 7A is a side cutaway illustration of another embodiment of adelivery device in a delivery configuration.

FIG. 7B is a side cutaway illustration of the delivery device of FIG. 7Awith the capsule retracted and the balloon in an inflated configuration.

FIG. 8A is a side cutaway illustration of another embodiment of adelivery device in a delivery configuration including a second balloonin an uninflated configuration.

FIG. 8B is a side cutaway illustration of the delivery device of FIG. 8Awith the capsule retracted and the balloons in an inflatedconfiguration.

FIG. 9A is a side cutaway illustration of another embodiment of adelivery device in a delivery configuration, wherein the delivery deviceincludes a dumbbell-shaped balloon.

FIG. 9B is a side cutaway illustration of the delivery device of FIG. 9Awith the capsule retracted and the dumbbell-shaped balloon in aninflated configuration.

FIG. 10A is a side cutaway illustration of another embodiment of adelivery device in a delivery configuration, wherein the delivery deviceincludes a balloon.

FIG. 10B is a side cutaway illustration of the delivery device of FIG.10A with the capsule retracted and the balloon in an inflatedconfiguration.

FIG. 100 is an end illustration of the balloon of FIG. 10B.

FIGS. 11A-11D are illustrations of another embodiment of a heart valveprosthesis including a torque anchoring mechanism.

FIGS. 12A-12B are end views of the heart valve prosthesis of FIGS.10A-10C in a pre-deployment configuration and a deployed configuration.

FIG. 12C is an end view of an alternative embodiment of the heart valveprosthesis of FIGS. 11A-11C.

FIG. 13 is a perspective illustration of a heart valve prosthesis with atorque anchoring mechanism according to another embodiment hereof.

FIG. 14 is an exploded perspective illustration of an embodiment of adelivery device according to an embodiment hereof.

FIG. 15 is a side view illustration of the delivery device of FIG. 14.

FIG. 16 is a side illustration of the delivery device of FIG. 14 andheart valve prosthesis of FIG. 13.

FIG. 17 is an exploded perspective illustration of an embodiment of adelivery device according to an embodiment hereof.

FIG. 18 is a side view illustration of the delivery device of FIG. 17.

FIG. 19 is a side illustration of the delivery device of FIG. 17 andheart valve prosthesis of FIG. 13.

FIGS. 20-24 are schematic illustrations of a method of delivering aheart valve prosthesis.

FIGS. 25-29 are schematic illustrations of another method of deliveringa heart valve prosthesis.

FIGS. 30-34 are schematic illustrations of another method of deliveringa heart valve prosthesis.

FIG. 35 is a schematic illustration of another embodiment of a heartvalve prosthesis including a torque anchoring mechanism.

FIG. 36 is a schematic cross-section of a variation of the heart valveprosthesis of FIG. 35.

DETAILED DESCRIPTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal”, when used in the following description to refer to acatheter or delivery device, are with respect to a position or directionrelative to the treating clinician. Thus, “distal” and “distally” referto positions distant from, or in a direction away from, the clinicianand “proximal” and “proximally” refer to positions near, or in adirection toward, the clinician. When the terms “distal” and “proximal”are used in the following description to refer to a device to beimplanted into a vessel, such as a heart valve prosthesis, they are usedwith reference to the direction of blood flow. Thus, “distal” and“distally” refer to positions in a downstream direction with respect tothe direction of blood flow and “proximal” and “proximally” refer to anupstream direction with respect to the direction of blood flow.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Furthermore, there is no intention to be bound by anyexpressed or implied theory presented in the preceding technical field,background, brief summary, or the following detailed description.

As referred to herein, a heart valve prosthesis used in accordance withand/or as part of the various systems, devices, and methods of thepresent disclosure may include a wide variety of differentconfigurations, such as a bioprosthetic heart valve having tissueleaflets or a synthetic heart valve having polymeric, metallic, ortissue-engineered leaflets, and can be specifically configured forreplacing any heart valve.

In general terms, the heart valve prosthesis, or stented prostheticheart valve as it is sometimes referred to, of the present disclosureincludes a frame supporting a valve structure (tissue or synthetic),with the frame having a normal, radially expanded configuration that iscollapsible to a radially compressed configuration for loading within oron a delivery device. The stent is may be constructed to self-deploy orexpand when released from the delivery device, or may beballoon-expandable.

FIG. 1 shows an embodiment of a heart valve prosthesis 10. FIG. 1illustrates heart valve prosthesis 10 in a radially expandedconfiguration. Heart valve prosthesis 10 includes a frame 14 and aprosthetic valve 12 coupled to the frame 14. Heart valve prosthesis 10includes a radially collapsed configuration and the radially expandedconfiguration. Heart valve prosthesis 10 also includes a first end 26and a second end 32 opposite first end 26. Frame 14 is generally tubularand defines a central passage 24, and includes a first end 34 and asecond end 36. In the embodiment shown in FIG. 1, first end 34 of frame14 defines first end 26 of heart valve prosthesis 10. Similarly, secondend 36 of frame 14 defines second end 32 of heart valve prosthesis 10.Those skilled in the art would recognize that other features, such asskirts or arms may be included as part of heart valve prosthesis 10. Inthe embodiment shown, first end 26 of heart valve prosthesis 10 is theproximal or inflow end, and second end 32 of heart valve prosthesis 10is the distal or outflow end. Also, first end 34 of frame 14 is flaredradially outwardly, as show in FIG. 1. This outward flare at first end34 forms an inflow rim 15 that is configured to contact an atrial sideof a native mitral valve annulus. Further, although inflow rim 15 isshown as generally circular, inflow rim may be other shapes to conformto the anatomy adjacent the native mitral valve, such as but not limitedto D-shaped. A portion of frame 14 may also be described as an outflowportion 25. Outflow portion 25 is generally tubular and is configured toextend through the leaflets of the native valve complex. Although heartvalve prosthesis 10 as shown is configured for placement at the site ofa native mitral valve, heart valve prosthesis 10 may be used at otherimplantation sites, such as, but not limited to, sites of other nativeheart valves.

Frame 14 is a support structure that comprises struts 16 arrangedrelative to each other with a plurality of open spaces 17 there between.Frame 14 provides a desired compressibility and expansion force at thedesired implantation site. Frame 14 also provides support for prostheticvalve 12. Prosthetic valve 12 is coupled to and disposed within frame14. In the embodiment of FIG. 1, a radially outward portion of inflowrim 15 bends such that the radially outward portion of inflow rim 15extends generally longitudinally away from second end 36 of frame 14.Struts 16 of inflow rim 15 bend and form a plurality of peaks 18 andvalleys 20 at a first end of inflow rim 15.

A plurality of torque anchoring mechanisms 22 are coupled to inflow rim15. In the embodiment shown in FIG. 1, torque anchoring mechanism 22 arecoupled to valleys 20 of inflow rim 15, but may be coupled to otherportions of inflow rim 15. Torque anchoring mechanisms 22 are configuredsuch that when heart valve prosthesis 10 is in the radially expandedconfiguration at a desired implantation site, and at least a portion ofheart valve prosthesis 10 is rotated, torque anchoring mechanisms 22 areembedded into tissue at the desired implantation site. As shown in FIG.1, torque anchoring mechanisms 22 extend clockwise. However, they mayextend counter-clockwise or partially angled in either direction.Further, torque anchoring mechanisms 22 may generally extend from anunderside 19 of inflow rim 15. The underside 19 of inflow rim 15 is thesurface facing the native mitral valve annulus when the heart valveprosthesis 10 is deployed with inflow rim 15 on the atrial side of thenative mitral valve annulus (i.e., the surface of the inflow rim facingthe outflow end). Torque anchoring mechanisms 22 may be barbs, clips,hooks, arrows or similar devices configured to embed into tissue at thedesired implantation site. While FIG. 1 shows each torque anchoringmechanism 22 as single wire, this is not limiting and otherconfigurations of torque anchoring mechanisms may be used.

Frame 14 may be formed, for example, and not by way of limitation, ofnickel titanium alloys (e.g., Nitinol),nickel-cobalt-chromium-molybdenum alloys (e.g., MP35N),cobalt-chromium-tungsten-nickel alloys (L605), stainless steel, highspring temper steel, or any other metal or suitable for purposes of thepresent disclosure. Torque anchoring mechanisms 22 may be formed fromthe same types of materials as frame 14. Torque anchoring mechanisms 22may be extensions of struts 16, or may be coupled to frame 14, forexample, and not by way of limitation, by fusing, welding, adhesive,sutures, snap-fit, interference fit, other mechanical engagements, orother means suitable for the purposed described herein.

With the above understanding of heart valve prosthesis 10 in mind, adelivery device 100 consistent with components, methods, and proceduresof the current disclosure is shown in FIGS. 2-5. In an embodiment,delivery device 100 generally includes a handle 140, an outer shaftassembly 110 including a capsule 107, an inner shaft assembly 104, and aballoon 150 (not shown in FIG. 2). Delivery device 100 may be anystandard construction delivery device, such as, but not limited to,multi-lumen or coaxial construction delivery devices. In otherembodiments, capsule 107 is not required, such as when using a balloonexpandable heart valve prosthesis, or a self-expandable heart valveprosthesis with other means to maintain the heart valve prosthesis in aradially collapsed configuration. A guidewire lumen 123 is disposedthrough inner shaft assembly 104 such that delivery device 100 may beadvanced over a guidewire (not shown) disposed within guidewire lumen123. Delivery device 100 may be made from any suitable material, suchas, but not limited to polyethylene (PE), polyethylene terephthalate(PET), polyether block amide (PEBA, such as PEBAX®), nylons,polyurethanes, polyvinylchloride (PVC), and metal hypotubes such asstainless steel.

Delivery device 100 is used for percutaneously delivering, implanting,and anchoring heart valve prosthesis 10 with torque anchoring mechanisms22 according to an embodiment of the present invention. FIG. 2illustrates an embodiment of delivery device 100 with heart valveprosthesis 10 in the radially collapsed configuration disposed withincapsule 107 of outer shaft assembly 110. In other embodiments, heartvalve prosthesis 10 may be mounted on a balloon without a capsule, or aself-expandable heart valve prosthesis may be mounted with other meansto maintain the heart valve prosthesis in a radially collapsedconfiguration. Delivery device 100 and heart valve prosthesis 10 areconfigured such that when heart valve prosthesis 10 is positioned at adesired implantation site and in the radially expanded configuration,rotating delivery device 100 rotates at least a portion of heart valveprosthesis 10, and torque anchoring mechanism 22 is embedded in tissueat the implantation site, as will be described in greater detail herein.

Components in accordance with an exemplary embodiment of delivery device100 of FIG. 2 are presented in greater detail in FIGS. 3-6B. Variousfeatures of the components of delivery device 100 reflected in FIGS.2-6B and described below can be modified or replaced with differingstructures and/or mechanisms. The components of delivery device 100 mayassume different forms and construction. Therefore, the followingdetailed description is not meant to be limiting. Further, the systemsand functions described below can be implemented in many differentembodiments of hardware. Any actual hardware described is not meant tobe limiting. The operation and behavior of the systems and methodspresented are described with the understanding that modifications andvariations of the embodiments are possible given the level of detailpresented.

In an embodiment shown schematically in FIGS. 3-4, handle 140 mayinclude a housing 142 and an actuator mechanism 144. More particularly,handle 140 includes a cavity 143 (FIG. 4) defined by housing 142 andconfigured to receive portions of actuator mechanism 144. In anembodiment shown in FIGS. 2-4, housing 140 may include a longitudinalslot 146 through which actuator mechanism 144 extends for interfacing bya user. Handle 140 provides a surface for convenient handling andgrasping by a user, and may have a generally cylindrical shape as shown.While handle 140 of FIGS. 2-4 is shown with a cylindrical shape, it isnot meant to limit the design, and other shapes and sizes arecontemplated based on the application requirements. Actuator mechanism144 is generally constructed to provide selective retraction/advancementof outer shaft assembly 110. Although shown as a slide mechanism, otherconstructions and/or devices may be used to retract/advance outer shaftassembly 110, such as, but to limited to rotating mechanisms, slidingmechanisms that are coaxially disposed over inner shaft assembly 104,combinations of rotating and sliding mechanisms, and otheradvancement/retraction mechanisms known to those skilled in the art.

Outer shaft assembly 110 is slidably disposed over inner shaft assembly104. With reference to FIGS. 3-4, in an embodiment, outer shaft assembly110 includes a proximal shaft 118 and a capsule 107, and defines a lumen112 extending from a proximal end 130 of proximal shaft 118 to a distalend 132 of capsule 107. Although outer shaft 110 is described herein asincluding capsule 107 and proximal shaft 118, capsule 107 may simply bean extension of proximal shaft 118. Further, outer shaft 110 may bereferred to as a sheath or outer sheath. Proximal shaft 118 isconfigured for fixed connection to capsule 107 at a connection point 116at a proximal end 109 of capsule 107 by fusing, welding, adhesive,sutures, or other means suitable for the purposes described herein.Alternatively, proximal shaft 118 and capsule 107 may be unitary.Proximal shaft 118 extends proximally from capsule 107 and proximalshaft 118 is configured for connection to handle 140. More particularly,proximal shaft 118 extends proximally into housing 142 of handle 140 anda proximal portion 131 of proximal shaft 118 is connected to actuatormechanism 144 of handle 140. Proximal portion 131 is coupled to actuatormechanism 144 such that movement of actuator mechanism 144 causes outershaft assembly 110 to move relative inner shaft assembly 104. Proximalshaft 118 may be coupled to actuator mechanism 144, for example, and notby way of limitation, by adhesives, welding, clamping, and othercoupling devices as appropriate. Outer shaft assembly 110 is thusmovable relative to handle 140 and inner shaft assembly 104 by actuatormechanism 144. However, if actuator mechanism 144 is not moved andhandle 140 is moved, outer shaft assembly 110 moves with handle 140, notrelative to handle 140.

Inner shaft assembly 104 extends within lumen 112 of outer shaftassembly 110, as shown at least in FIG. 4. Inner shaft assembly 104includes an inner shaft 114, a distal tip 122, and balloon 150,described in greater detail below. Inner shaft 114 extends from aproximal end 134 of inner shaft 114 to a distal end 136. Distal end 136of inner shaft 114 is attached to distal tip 122. The components ofinner shaft assembly 104 combine to define a guidewire lumen 123, whichis sized to receive an auxiliary component such as a guidewire (notshown) and an inflation lumen 192, described in greater detail below. Inthe embodiments shown, delivery device 100 includes an over-the-wire(OTW), multi-lumen configuration with guidewire lumen 123 extendingsubstantially the entire length of inner shaft assembly 104. However,other configurations, such as rapid exchange configurations, may also beused. Proximal end 134 of inner shaft 114 may be attached to handle 140or may be attached to another device such as a hub. Inner shaft 114 maybe coupled to handle 140, for example, and not by way of limitation, byadhesives, welding, clamping, and other coupling devices as appropriate.During sliding or longitudinal movement of outer shaft assembly 110relative to inner shaft assembly 104, inner shaft 114 may be fixedrelative to handle 140.

As previously noted, inner shaft assembly 114 includes an inflationlumen 192 and a guidewire lumen 123 extending therethrough. FIG. 5 showsa cross-sectional view of inner shaft 114 disposed within outer shaftassembly 110. As shown in FIG. 5, guidewire lumen 123 and inflationlumen 192 extend through inner shaft 114. In the embodiment shown,inflation lumen 192 and guidewire lumen 123 are two lumens extendingthrough a single shaft. However, other constructions may also be used.

FIGS. 6A and 6B show a distal portion of delivery device 100 with heartvalve prosthesis 10 disposed therein in a delivery configuration. Heartvalve prosthesis 10 is disposed within capsule 107 of outer shaftassembly 110 and over inner shaft 114. Balloon 150 is disposed proximalof heart valve prosthesis 10 and is coupled to inner shaft 114. In thedelivery configuration shown in FIG. 6A, balloon 150 is disposed withinouter shaft assembly 110. In the embodiment shown in FIGS. 6A and 6B,proximal end 154 of balloon 150 is attached to inner shaft 114 at aproximal bond 155. Similarly, distal end 156 of balloon 150 is attachedto inner shaft 114 at a distal bond (not shown). Inner shaft 114continues distally beyond the distal bond of balloon 150/inner shaft114. Inflation lumen 192 includes an inflation port 196 that opens intoan interior 151 of balloon 150.

Distal end 156 of balloon 150 may also be described as a shaped end 152.Shaped end 152 is shaped to engage first end 34 of frame 14 of heartvalve prosthesis 10. In an embodiment, shaped end 152 includes aplurality of peaks 158 extending distally and valleys 160 extendingproximally. Peaks 158 and valleys 160 are spaced radially from thecentral longitudinal axis LA_(c). Peaks 158 and valleys 160 may bearranged opposite of peaks 18 and valleys 20 of first end 34 of frame14; in particular, the radially outer portion of inflow rim 15 ofFIG. 1. Balloon 150 is in an uninflated configuration and disposedwithin outer shaft assembly 110 for delivery, as shown in FIG. 6A, andis inflated to an inflated configuration to engage and rotate frame 14,as shown in FIG. 6B. Balloon 150 may be a compliant high frictionballoon constructed of any suitable material, such as, but not limitedto, polyethylene terephthalate (PET), nylon, or polyurethane. Moreover,balloon 150 may include a three-dimensional pattern, or texture, on anouter surface to increase engagement (frictional contact) with the heartvalve prosthesis 10 when the balloon is in the second (inflated)configuration.

With the above understanding of components in mind, operation andinteraction of components of the present disclosure may be explainedherein. As shown in FIG. 6A, heart valve prosthesis 10 is disposed in aradially compressed configuration within capsule 107 of outer shaftassembly 110. Balloon 150 is also uninflated. Delivery device 100 isdelivered to an implantation site, such as the site of a native mitralvalve. When at the implantation site, outer shaft assembly 110 isretracted proximally, thereby retracting capsule 107 proximally. Capsule107 is retracted proximally sufficiently to expose heart valveprosthesis 10. In the embodiment shown, heart valve prosthesis 10 isself-expanding. Therefore, retraction of capsule 107 enables heart valveprosthesis 10 to self-expand to the radially expanded configuration.Capsule 107 may be retracted further proximally, or may have beenretracted further initially, such that balloon 150 is not covered bycapsule 107. An inflation fluid, such as but not limited to saline, isinjected through inflation lumen 192, out of inflation port 196, andinto the interior 151 of balloon 150, thereby inflating balloon 150, asshown in FIG. 6B. Delivery device 100 may be rotated to align shaped end152 of balloon 150 with the shaped first end 34 of frame 14 of heartvalve prosthesis 10, if necessary. Delivery device 100 may also beadvanced longitudinally, if necessary, such that shaped end 152 ofballoon 150 engages the shaped end first end 34 of frame 14 of heartvalve prosthesis 10, as shown in FIG. 6B. In an engagement embodiment,peaks 158 of balloon 150 engage corresponding valleys 20 of heart valveprosthesis 10, and valleys 160 of balloon 150 engage corresponding peaks18 of heart valve prosthesis 10.

With shaped end 152 of balloon 150 engaged with shaped first end 24 offrame 14 of heart valve prosthesis 10, delivery device 100 may berotated in a direction R_(r) relative to central longitudinal axisLA_(c), thereby rotating shaped end 152 of balloon 150 in directionR_(r) such that shaped end 152 applies a rotational torque in directionR_(r) to engaged corresponding shaped first end 34 of frame 14. Thisrotational torque rotates heart valve prosthesis 10 in direction R_(r)such that torque anchoring mechanisms 22 are embedded in tissue at thedesired implantation site. Stated another way, with balloon 150inflated, heart valve prosthesis 10 in the radially expandedconfiguration, and shaped end 152 of balloon 150 engaged with shapedfirst end 26 of heart valve prosthesis 10, delivery device 100 isrotated in direction R_(r) to embed torque anchoring mechanisms 22 intissue, thereby anchoring heart valve prosthesis 10 to tissue at thedesired implantation site. Balloon 150 may then be deflated and deliverydevice 100 may be withdrawn from the patient, leaving heart valveprosthesis 10 implanted at the desired implantation site.

FIGS. 6A-6B shows a particular embodiment of balloon 150 and heart valveprosthesis 10. As explained above, this particular embodiment is notmeant to limit the design. Therefore, for example and not by way oflimitation, shaped end 152 of balloon 150 may be at proximal end 154instead of distal end 156, and heart valve prosthesis 10 would bedisposed proximal of balloon 150 such that proximal end 154 of balloon150 could engage a shaped distal end of heart valve prosthesis 10.Further, the specific number of peaks 158 and valleys 160 of balloon 150shown in FIGS. 6A and 6B is merely an example, and may be increased ordecreased to match a corresponding number of peaks and valleys in theshaped end of heart valve prosthesis 10.

FIGS. 7A-7B illustrate a distal portion of another embodiment of adelivery device 100′ for delivering and deploying a heart valveprosthesis 10. Delivery device 100′ is similar to the embodiment ofFIGS. 6A-6B, so only the differences between the embodiments will bedescribed in detail here. Features not specifically described may belike those described with respect to the embodiment of FIGS. 6A-6B, orother embodiments described herein. In the embodiment of FIGS. 7A-7B,instead of an inner shaft with a guidewire lumen 123 and an inflationlumen 192, as described above, inner shaft assembly 104′ includes aguidewire shaft 114′ with an inflation shaft 190 disposed coaxially overguidewire shaft 114′. A guidewire lumen 123′ extends through guidewireshaft 114′ and an inflation lumen 192′ is defined between an outersurface of guidewire shaft 114′ and an inner surface of inflation shaft190.

In the embodiment shown in FIGS. 7A-7B, proximal end 154 of balloon 150is attached to inflation shaft 190 at a proximal bond 155′. Inflationshaft 190 terminates prior to distal end 156 of balloon 150 such that aninflation port 196′ is formed between a distal end 194 of inflationshaft and guidewire shaft 114′. Distal end 156 of balloon 150 isattached to guidewire shaft 114′ at a distal bond (not shown). When aninflation fluid is injection into inflation lumen 192′, the inflationfluid exits inflation lumen 192′ through inflation port 196′ and intothe interior 151 of balloon 150, thereby inflating balloon 150, as shownin FIG. 7B.

FIGS. 8A-8B illustrate a distal portion of another embodiment of adelivery device 100″. Delivery device 100″ includes a first balloon 150and a second balloon 162. FIG. 8A shows delivery device 100″ with heartvalve prosthesis 10 including torque anchoring mechanisms 22 disposedtherein. FIG. 8A shows delivery device 100″ in a delivery configurationwith first balloon 150, second balloon 162, and heart valve prosthesis10 disposed within outer shaft assembly 110 such that first balloon 150and second balloon 162 are uninflated, and heart valve prosthesis 10 isin a radially compressed configuration.

Delivery device 100″ is similar to delivery device 100 except for theaddition of second balloon 162 and extension of inflation lumen 192″distally to second balloon 162. Therefore, except for the differencesspecifically noted below, elements of delivery device 100″ may be thesame as or similar to the corresponding elements of FIGS. 2-6B. Inparticular, the proximal portion of delivery device 100″ is notdescribed in detail and may be similar to the proximal portion ofdelivery device 100 described above with respect to FIGS. 2-4.

As shown in FIGS. 8A-8B, second balloon 162 includes a proximal end 164attached to inner shaft inner shaft 114 at a proximal bond 163 and adistal end 166 attached to inner shaft 114 at a distal bond 165. Secondballoon 162 is disposed distal of heart valve prosthesis such thatproximal end 164 of second balloon is adjacent second end 32 of heartvalve prosthesis 10. First balloon 150 is disposed proximal of heartvalve prosthesis 10 and is coupled to inner shaft 114. In the deliveryconfiguration shown in FIG. 8A, balloon 150 is disposed within outershaft assembly 110. In the embodiment shown in FIGS. 8A-8B, proximal end154 of first balloon 150 is attached to inner shaft 114 at a proximalbond 155 and distal end 156 of balloon 150 is attached to inner shaft114 at a distal bond 157. Inner shaft 114 continues distally beyonddistal bond 155.

Inflation lumen 192″ of inner shaft 114 is extended distally to a secondinflation port 208 which opens to an interior of second balloon 162.Second inflation port 208 is disposed between proximal end 164 anddistal end 166 of second balloon 162 such that inflation fluid injectedthrough inflation lumen 192″ exits second inflation portion 208 into aninterior of second balloon 162, thereby inflating second balloon 162. Asin the embodiment of FIGS. 6A-6B, inflation fluid injected intoinflation lumen 192″ exits inflation portion 196″ into an interior 151of first balloon 150, thereby inflating first balloon 150.

As in the embodiment of FIGS. 6A-6B, distal end 154 of balloon 150 is ashaped end 152 shaped to engage first end 34 of frame 14 of heart valveprosthesis 10. In an embodiment, shaped end 152 includes a plurality ofpeaks 158 extending distally and valleys 160 extending proximally. Peaks158 and valleys 160 are spaced radially from the central longitudinalaxis LAc. Peaks 158 and valleys 160 are arranged opposite of peaks 18and valleys 20 of first end 34 of frame 14. First balloon 150 is in anuninflated configuration and disposed within outer shaft assembly 110for delivery, as shown in FIG. 8A, and is inflated to an inflatedconfiguration to engage and rotate frame 14, as shown in FIG. 8B. Firstballoon 150 may be a compliant high friction balloon constructed of anysuitable material, such as, but not limited to, polyethyleneterephthalate (PET), nylon, or polyurethane.

With the above understanding of components in mind, operation andinteraction of components of the present disclosure may be explainedherein. As shown in FIG. 8A, heart valve prosthesis 10 is disposed in aradially compressed configuration within capsule 107 of outer shaftassembly 110. First balloon 150 and second balloon 162 are uninflated.Delivery device 100″ is delivered to an implantation site, such as thesite of a native mitral valve. When at the implantation site, outershaft assembly 110 is retracted proximally, thereby retracting capsule107 proximally. Capsule 107 is retracted proximally sufficiently toexpose heart valve prosthesis 10. In the embodiment shown, heart valveprosthesis 10 is self-expanding. Therefore, retraction of capsule 107enables heart valve prosthesis 10 to self-expand to the radiallyexpanded configuration. Capsule 107 may be retracted further proximally,or may have been retracted further initially, such that first balloon150 is not covered by capsule 107. An inflation fluid, such as but notlimited to saline, is injected through inflation lumen 192″, out ofinflation ports 196″ and 206, and into the interior 151 of first balloon150 and the interior of second balloon 162, thereby inflating firstballoon 150 and second balloon 162, as shown in FIG. 8B. Delivery device100″ may be rotated to align shaped end 152 of first balloon 150 withthe shaped first end 34 of frame 14 of heart valve prosthesis 10, ifnecessary. Delivery device 100 may also be advanced longitudinally, ifnecessary, such that shaped end 152 of first balloon 150 engages theshaped first end 34 of frame 14 of heart valve prosthesis 10, as shownin FIG. 8B. In an engagement embodiment, peaks 158 of first balloon 150engage corresponding valleys 20 of heart valve prosthesis 10, andvalleys 160 of first balloon 150 engage corresponding peaks 18 of heartvalve prosthesis 10. In particular, shaped end 152 of first balloon 150engages the peaks and valleys of the radially outward, bent portion ofinflow rim 15 of heart valve prosthesis 10

When second balloon 162 is inflated, proximal end 164 may engage distalend 32 of heart valve prosthesis 10 when heart valve prosthesis 10 is inthe radially expanded configuration, as shown in FIG. 8B. Second balloon162 is configured to provide longitudinal stability for heart valveprosthesis 10 along central longitudinal axis LA_(c) relative todelivery device 100″ as heart valve prosthesis 10 is rotated and torqueanchoring mechanisms 22 are embedded in tissue at desired implantationsite. Second balloon 162 may be a compliant high friction balloonconstructed of any suitable material, such as, but not limited to,polyethylene terephthalate (PET), nylon, or polyurethane.

With shaped end 152 of first balloon 150 engaged with shaped first end24 of frame 14 of heart valve prosthesis 10 and second balloon 162abutting second end 36 of frame 14, delivery device 100″ may be rotatedin a direction R_(r) relative to central longitudinal axis LA_(c),thereby rotating shaped end 152 of first balloon 150 in direction R_(r)such that shaped end 152 applies a rotational torque in direction R_(r)to engaged corresponding shaped first end 34 of frame 14. Thisrotational torque rotates heart valve prosthesis 10 in direction R_(r)such that torque anchoring mechanisms 22 are embedded in tissue at thedesired implantation site. Stated another way, with first balloon 150and second balloon 162 inflated, heart valve prosthesis 10 in theradially expanded configuration, and shaped end 152 of balloon 150engaged with shaped first end 26 of heart valve prosthesis 10, deliverydevice 100″ is rotated in direction R_(r) to embed torque anchoringmechanisms 22 in tissue, thereby anchoring heart valve prosthesis 10 totissue at the desired implantation site. First and second balloons 150,162 may then be deflated and delivery device 100″ may be withdrawn fromthe patient, leaving heart valve prosthesis 10 implanted at the desiredimplantation site.

FIGS. 8A-8B show the inflation lumen 192″ and guidewire lumen 123extending through the inner shaft 114, similar to the embodiment ofFIGS. 6A-6B. However, instead of a single inflation lumen 192″, theremay be two inflation lumens; one for first balloon 150 and another forsecond balloon 162. Additionally, instead of multiple lumens through aninner shaft, multiple coaxial shafts with annular lumen(s) may be used,similar the embodiment of FIGS. 7A-7B. In such an embodiment, a singleinflation shaft may be used with an inflation lumen between theguidewire shaft and the inflation shaft. The inflation shaft extends tothe second balloon with an inflation port through the inflation shaft atthe first balloon and an inflation port opening at the second balloon.Alternatively, two annular inflation shafts may be used, one terminatingat the first balloon and the second terminating at the second balloon.Other arrangements of guidewire lumens and inflation lumens may beutilized as would be understood to those skilled in the art.

FIGS. 9A-9B illustrate a distal portion of another embodiment of adelivery device 100′″. Delivery device 100′″ includes a dumbbell-shapedballoon 170. FIG. 9A shows delivery device 100′″ with heart valveprosthesis 10 including torque anchoring mechanisms 22 disposed therein.FIG. 9A shows delivery device 100′″ in a delivery configuration withdumbbell-shaped balloon 170 and heart valve prosthesis disposed withinouter shaft assembly 110 with dumbbell-shaped balloon 170 uninflated andheart valve prosthesis 10 in a radially compressed configuration.

Delivery device 100′″ is similar to delivery device 100 of FIGS. 2-6Bexcept that dumbbell-shaped balloon 170 replaces balloon 150 andinflation lumen 210 of FIGS. 9A-9B is different from inflation lumen 192of FIGS. 2-6B. Therefore, except for the differences specifically notedbelow, elements of delivery device 100′″ are the same as or similar tothe corresponding elements of FIGS. 2-6B. In particular, the proximalportion of delivery device 100′″ is not described in detail and may besimilar to the proximal portion of delivery device 100 described abovewith respect to FIGS. 2-4.

As shown in FIG. 9B, dumbbell-shaped balloon 170 includes first portion172, a second portion 180, and a third portion 186 disposed betweenfirst portion 172 and second portion 180. A proximal end 176 of firstportion 172 is attached to inner shaft 114 at a proximal bond 175 and adistal end 184 of second portion 180 is attached to inner shaft 114 at adistal bond 185, as shown in FIG. 9A. First portion 172 of balloon 170is disposed proximal of heart valve prosthesis 10 and second portion 180is disposed distal of heart valve prosthesis 10. Third portion 186 ofdumbbell-shaped balloon 170 is disposed under heart valve prosthesis 10.In other words, heart valve prosthesis 10 is disposed on third (middle)portion 186 of dumbbell-shaped balloon 170. In the deliveryconfiguration shown in FIG. 9A, dumbbell-shaped balloon 170 is disposedwithin outer shaft assembly 110. In the embodiment of FIGS. 9A-9B,dumbbell-shaped balloon 170 is a single balloon shaped to form theportions noted above and described in more detail below. However,dumbbell-shaped balloon 170 may instead be three separate balloons.Alternatively, dumbbell-shaped balloon 170 may be a single balloon andthe three portions noted above may be separate compartments of theballoon.

Inner shaft assembly 104 of FIGS. 9A-9B is similar to inner shaftassembly 104 of FIGS. 6A-6B, including an inner shaft 114 having aguidewire lumen 123 and an inflation lumen 210 extending therethrough.Inflation lumen 210 is in fluid communication with dumbbell-shapedballoon 170. In the embodiment shown in FIGS. 9A-9B, inflation lumenincludes a first inflation portion 216 in fluid communication with firstportion 172, a second inflation port 218 in fluid communication withsecond portion 180, and a third inflation portion 220 in fluidcommunication with opening third portion 186. However, ifdumbbell-shaped balloon 170 is a single balloon with a single interior,as explained above, an inflation portion for each portion is notnecessary. If each portion of dumbbell-shaped balloon 170 is a separateballoon or the portions are separate compartments, at least threeinflation ports are needed, one for each balloon/compartment.

As shown in FIG. 9B, a distal end 178 of first potion 172 ofdumbbell-shaped balloon 170 is a shaped end 174 shaped to engage firstend 34 of frame 14 of heart valve prosthesis 10. In an embodiment,shaped end 174 includes a plurality of peaks 175 extending distally anda plurality of valleys 177 extending proximally. Peaks 175 and valleys177 are spaced radially from the central longitudinal axis LAc. Peaks175 and valleys 177 are arranged opposite of peaks 18 and valleys 20 offirst end 34 of frame 14. Dumbbell-shaped balloon 170 is in anuninflated configuration and disposed within outer shaft assembly 110for delivery, as shown in FIG. 9A, and is inflated to an inflatedconfiguration to engage and rotate frame 14, as shown in FIG. 9B.Dumbbell-shaped balloon 170 may be a compliant high friction balloonconstructed of any suitable material, such as, but not limited to,polyethylene terephthalate (PET), nylon, or polyurethane.

FIG. 9B shows dumbbell-shaped balloon 170 in the inflated configuration.First portion 172 of dumbbell shaped balloon 170 has a first expandeddiameter D_(f) in the inflated configuration. Second portion 180 ofdumbbell-shaped balloon 170 has a second expanded diameter D_(s) in theinflated configuration. A proximal end 182 of second portion 180 isconfigured such that proximal end 182 abuts second end 32 of heart valveprosthesis 10. Second portion 180 is configured to provide longitudinalstability for heart valve prosthesis 10 along central longitudinal axisLA_(c) relative to delivery device 100′″ as heart valve prosthesis 10 isrotated and torque anchoring mechanisms 22 are embedded in tissue atdesired implantation site. Stated another way, when second portion 180of dumbbell-shaped balloon 170 is in the inflated configuration, secondportion 180 is configured to prevent shaped end 26 of heart valveprosthesis 10 from disengaging from shaped end 174 of first portion 172of dumbbell-shaped balloon 170. Third portion 186 of dumbbell-shapedballoon 170 has a third expanded diameter D_(t) when in the inflatedconfiguration. Third portion 186 is configured such that when thirdportion 186 is in the inflated configuration, an outer surface 189 ofthird portion 186 engages an inner surface of heart valve prosthesis 10.Stated another way, when third portion 186 of dumbbell-shaped balloon170 is in the inflated configuration, third portion 186 provides radialforce outward from central longitudinal axis LA_(c), supporting frame 14of heart valve prosthesis 10. When first, second, and third portions172, 180, and 186 are each in the inflated configuration, third expandeddiameter D_(t) is smaller than both first expanded diameter D_(f) andsecond expanded diameter D_(s).

With the above understanding of components in mind, operation andinteraction of components of the present disclosure may be explainedherein. As shown in FIG. 9A, heart valve prosthesis 10 is disposed in aradially compressed configuration within capsule 107 of outer shaftassembly 110. Dumbbell shaped balloon 170 is uninflated. In otherembodiments, and particularly with third portion 186 of dumbbell-shapedballoon 170 engaging an inner surface of heart valve prosthesis 10,capsule 107 may be excluded. In particular, heart valve prosthesis 10may be balloon-expandable. Delivery device 100′″ is delivered to animplantation site, such as the site of a native mitral valve. When atthe implantation site, outer shaft assembly 110 is retracted proximally,thereby retracting capsule 107 proximally. Capsule 107 is retractedproximally sufficient to expose heart valve prosthesis 10. In theembodiment shown, heart valve prosthesis 10 is self-expanding.Therefore, retraction of capsule 107 enables heart valve prosthesis 10to self-expand to the radially expanded configuration. Capsule 107 maybe retracted further proximally, or may have been retracted furtherinitially, such that first portion 172 of dumbbell shaped balloon 170 isnot covered by capsule 107. An inflation fluid, such as but not limitedto saline, is injected through inflation lumen 210, out of inflationports 216, 218, and 220, and into the interiors of first, second, andthird portions 172, 180, and 186 of dumbbell-shaped balloon 170, therebyinflating dumbbell-shaped balloon 170, as shown in FIG. 9B. In otherembodiments, heart valve prosthesis 10 may be balloon-expandable andcapsule 107 may be eliminated. When such a delivery device is at theimplantation site, dumbbell-shaped balloon 170 is inflated, therebyexpanding heart valve prosthesis 10. Shaped end 174 of first portion 172of dumbbell-shaped balloon 170 is aligned with the shaped first end 34of frame 14 of heart valve prosthesis 10. In an embodiment, peaks 175 offirst portion 172 of dumbbell-shaped balloon 170 engage correspondingvalleys 20 of heart valve prosthesis 10, and valleys 177 ofdumbbell-shaped balloon 170 engage corresponding peaks 18 of heart valveprosthesis 10. Also, proximal end 182 of second portion 180 ofdumbbell-shaped balloon 170 abuts second end 34 of heart valveprosthesis 10. In an embodiment, heart valve prosthesis 10 may becompressively held between first portion 172 and third portion 186 ofballoon 170 when balloon 170 is in the second (inflated) configuration.

With shaped end 174 of first portion 172 of dumbbell shaped balloon 170engaged with shaped first end 24 of frame 14 of heart valve prosthesis10 and second portion 180 of dumbbell shaped balloon 170 abutting secondend 36 of frame 14, delivery device 100′″ may be rotated in a directionR_(r) relative to central longitudinal axis LA_(c), thereby rotatingdumbbell-shaped balloon 170 in direction R_(r) such that shaped end 174applies a rotational torque in direction R_(r) to engaged correspondingshaped first end 34 of frame 14. This rotational torque rotates heartvalve prosthesis 10 in direction R_(r) such that torque anchoringmechanisms 22 are embedded in tissue at the desired implantation site.Stated another way, with dumbbell shaped balloon 170 inflated, heartvalve prosthesis 10 in the radially expanded configuration, and shapedend 174 of first portion 172 of dumbbell shaped balloon 170 engaged withshaped first end 26 of heart valve prosthesis 10, delivery device 100′″is rotated in direction R_(r) to embed torque anchoring mechanisms 22 intissue, thereby anchoring heart valve prosthesis 10 to tissue at thedesired implantation site. Dumbbell-shaped balloon 170 may then bedeflated and delivery device 100′″ may be withdrawn from the patient,leaving heart valve prosthesis 10 implanted at the desired implantationsite.

FIGS. 10A-10C illustrate a distal portion of another embodiment of adelivery device 100″″. Delivery device 100″″ includes a balloon 250.FIG. 10A shows delivery device 100″″ with heart valve prosthesis 10including torque anchoring mechanisms 22 (FIG. 10B) disposed therein.FIG. 10A shows delivery device 100″″ in a delivery configuration withballoon 250 and heart valve prosthesis 10 disposed within outer shaftassembly 110. Balloon 250 is uninflated and heart valve prosthesis 10 isin a radially compressed configuration.

Delivery device 100″″ is similar to delivery device 100 of FIGS. 2-6Bexcept that balloon 250 replaces balloon 150 and is disposed withinheart valve prosthesis 10. Therefore, except for the differencesspecifically noted below, elements of delivery device 100″″ are the sameas or similar to the corresponding elements of FIGS. 2-6B. Inparticular, the proximal portion of delivery device 100″″ is notdescribed in detail and may be similar to the proximal portion ofdelivery device 100 described above with respect to FIGS. 2-4.

As shown in FIG. 10A, a proximal end 254 of balloon 250 is attached toinner shaft 114 at a proximal bond 255 and a distal end 256 is attachedto inner shaft 114 at a distal bond 257. Balloon 250 is disposed under(within) heart valve prosthesis 10. In other words, heart valveprosthesis 10 is disposed on balloon 250. In the delivery configurationshown in FIG. 10A, balloon 250 is thus disposed within outer shaftassembly 110.

Inner shaft assembly 104 of FIGS. 10A-10B is similar to inner shaftassembly 104 of FIGS. 6A-6B, including an inner shaft 114 having aguidewire lumen 123 and an inflation lumen 192 extending therethrough.Inflation lumen 192 is in fluid communication with balloon 250. In theembodiment shown in FIGS. 10A-10B, inflation lumen 192 includes aninflation port 196 in fluid communication with balloon 250.

As shown in FIG. 10B and in greater detail in FIG. 100, an outer surface253 of balloon 250 includes a shaped portion 252. In an embodiment,shaped portion 252 is configured to extend into open spaces 17 andengage frame 14 of heart valve prosthesis 10 when balloon 250 isinflated. In an embodiment, shaped portion 252 includes a plurality ofprotrusions 258 extending radially outward from the outer surface 253 ofballoon 250. Heart valve prosthesis 10 is loaded onto balloon 250 suchthat protrusions 258 are arranged opposite of corresponding open spaces17 of frame 14. Balloon 250 is in an uninflated configuration anddisposed within outer shaft assembly 110 for delivery, as shown in FIG.10A, and is inflated to an inflated configuration such that eachprotrusion 258 extends radially through corresponding open space 17.When in the inflated configuration, an outer surface of each protrusion258 engages adjacent struts 16 such that rotation of balloon 250 engagesand rotates frame 14, as shown in FIG. 10B. Balloon 250 may be acompliant high friction balloon constructed of any suitable material,such as, but not limited to, polyethylene terephthalate (PET), nylon, orpolyurethane.

FIG. 10B shows balloon 250 in the inflated configuration. Balloon 250 isfurther configured such that when balloon 250 is in the inflatedconfiguration, the outer surface 253 of balloon 250 engages an innersurface of heart valve prosthesis. Thus, when balloon 250 is in theinflated configuration, balloon 250 provides radial force outward fromcentral longitudinal axis LA_(c), supporting frame 14 of heart valveprosthesis 10 and is configured to engage and rotate frame 14.

With the above understanding of components in mind, operation andinteraction of components of the present disclosure may be explainedherein. As shown in FIG. 10A, heart valve prosthesis 10 is disposed inthe radially compressed configuration within capsule 107 of outer shaftassembly 110. Balloon 250 is in the uninflated configuration and isdisposed within heart valve prosthesis 10. In other embodiments, asexplained above, capsule 107 may be excluded. Delivery device 100″″ isdelivered to an implantation site, such as the site of a native mitralvalve. When at the implantation site, outer shaft assembly 110 isretracted proximally, thereby retracting capsule 107 proximally. Capsule107 is retracted proximally sufficient to expose heart valve prosthesis10 and balloon 250 therein. In the embodiment shown, heart valveprosthesis 10 is self-expanding. Therefore, retraction of capsule 107enables heart valve prosthesis 10 to self-expand to the radiallyexpanded configuration. An inflation fluid, such as but not limited tosaline, is injected through inflation lumen 192, out of inflation port196 and into the interior of balloon 250, thereby inflating balloon 250(transitioning from the uninflated to the inflated configuration), asshown in FIG. 10B. In other embodiments, heart valve prosthesis 10 maybe balloon-expandable and capsule 107 may be eliminated. When such adelivery device is at the implantation site, balloon 250 is inflated,thereby expanding heart valve prosthesis 10. Protrusions 258 of shapedportion 252 of balloon 250 are aligned with open spaces 17 betweenadjacent struts 16 of frame 14 of heart valve prosthesis 10.

With shaped portion 252 of balloon 250 engaged with open spaces 17 andstruts 16 of frame 14 of heart valve prosthesis 10, delivery device100″″ may be rotated in a direction R_(r) relative to centrallongitudinal axis LA_(c), thereby rotating balloon 250 in directionR_(r) such that shaped portion 252 applies a rotational torque indirection R_(r) to engaged corresponding frame 14. This rotationaltorque rotates heart valve prosthesis 10 in direction R_(r) such thattorque anchoring mechanisms 22 are embedded in tissue at the desiredimplantation site. Stated another way, with balloon 250 inflated, heartvalve prosthesis 10 in the radially expanded configuration, and shapedportion 252 of balloon 250 engaged with frame 14 of heart valveprosthesis 10, delivery device 100″″ is rotated in direction R_(r) toembed torque anchoring mechanisms 22 in tissue, thereby anchoring heartvalve prosthesis 10 to tissue at the desired implantation site. Balloon250 may then be deflated and delivery device 100″″ may be withdrawn fromthe patient, leaving heart valve prosthesis 10 implanted at the desiredimplantation site.

Features of any of the embodiments described above may be used with anyof the other embodiments described above. Further, variations in thenumber of balloons, inflation lumens, inflation ports, and similar itemsmay be made within the scope of the invention. For example, and not byway of limitation, the delivery devices described above and below mayalso include an outer stability shaft disposed outside of the outershaft assembly 110. Other details of the delivery devices may be asdescribed in U.S. Pat. No. 8,414,645 to Dwork; U.S. Pat. No. 8,876,893to Dwork; U.S. Pat. No. 8,926,692 to Dwork, each of which isincorporated in its entirety herein. Other materials than thosedescribed above may also be used within the scope of the invention.

FIGS. 11A-11D and 12A-12B illustrate another embodiment of a heart valveprosthesis 500 including a toque anchoring mechanism 530. Heart valveprosthesis 500 includes a frame 502 and a prosthetic heart valve 504(see FIGS. 11C-11D) coupled to the frame 502. Prosthetic heart valve 504may be any suitable prosthetic heart valve known to those skilled in theart, and may be bi-leaflet, tri-leaflet (shown) or any other suitabledesign. Frame 502 may include an inflow rim 510 and an outflow tube 520.Inflow rim 510 and outflow tube 520 need not be separate parts andgenerally may be a unitary with inflow rim 510 flaring radiallyoutwardly from outflow tube 520. Frame 502, including inflow rim 510 andoutflow tube 520 may be formed by a plurality of struts 512 with spacesor openings 513 formed there between, as known to those skilled in theart. Frame 502 is radially compressible for delivery and radiallyexpandable for deployment at the treatment site. FIGS. 11A-11D and12A-12B show frame 502 in a radially expanded configuration. Frame 502may be self-expanding or balloon expandable. Frame 502 may be formedfrom materials such as, but not limited to, nickel titanium alloys(e.g., Nitinol), nickel-cobalt-chromium-molybdenum alloys (e.g., MP35N),stainless steel, high spring temper steel, or any other metal or othermaterial suitable for purposes of the present disclosure.

Frame 502 defines a first or inflow end 506 and a second or outflow end508 of heart valve prosthesis 500. Frame 502 is generally tubular anddefines a central passage 524 therethrough. Prosthetic valve 504 isdisposed in the central passage 504, as shown in FIGS. 11C and 11D.

Torque anchoring mechanism 530 of heart valve prosthesis 500 includes aring 532 with a plurality of barbs 534 extending radially outwardly fromthe ring 532, as shown in FIGS. 11A-11D and 12A-12B. In the embodimentshown, ring 532 is disposed over (around) outflow tube 520 such that aninner surface of ring 532 circumscribes an outer surface of outflow tube520. Ring 532 is rotatable relative to outflow tube 520 and inflow ring510, as will be described in greater detail below. Ring 532 is alsoradially compressible and expandable such that ring 532 may be radiallycompressed for transluminal delivery and radially expandable at thetreatment site for deployment. Ring 532 may be self-expanding or balloonexpandable.

Each barb 534 includes distal tip 536 at an end opposite from ring 532.Distal tip 536 may be a sharp tip to assist in engagement with tissue.Each barb 534 may be formed separately from ring 532 and attachedthereto, or may be formed unitarily with ring 532. Barbs 534 are shownextending directly radially outwardly from ring 532 in FIGS. 11A-11D and12A. However, in the embodiment shown, barbs 534 are angled, as shown inFIG. 12B. In particular, each barb 534 includes a first portion 535extending directly radially outward from ring 532, a bend 533, and asecond portion 537 extending at an angle a with respect to the radialdirection R_(d) extending through the first portion of the same barb534, as shown in FIG. 12B. Angle α may be _10-_90 degrees. In theembodiment shown, barbs 534 are pre-set to the bent shape shown in FIG.12B and are held in the radially outward direction shown in FIGS.11A-11C and 12A by an outside force, described below. Thus, upon removalof the outside force, barbs 534 return to the pre-set bent shape shownin FIG. 12B. Although FIG. 12B shows a particular shape for barbs 534,it is not limiting. Other shapes, angles, and bends may be used inkeeping with the present disclosure. In order for barbs 534 to have apre-set bend, they may be formed of a shape memory material, including,but not limited to, nickel-titanium alloys (e.g. Nitinol),nickel-cobalt-chromium-molybdenum alloys (e.g., MP35N), stainless steel,high spring temper steel, or any other metal or other material suitablefor purposes of the present disclosure.

As shown in FIGS. 11A-11D and 12A, barbs 534 may be restrained in astraight, directly radially outward direction for delivery andpre-deployment. In particular, as shown in FIG. 11B, certain struts 512of inflow portion 510 may each include lips 514 that restrain a barb 534in the radially outward configuration. Lips 514 may be constructed as anextension of the respective strut 512 of the inflow portion. Lips 514may extend in a direction generally parallel to the longitudinal axis LAof the heart valve prosthesis 500, which is generally perpendicular tothe longitudinal axis of the respective barb 534 when in the restrained,generally radially outward direction. Lips 514 may instead beconstructed as a groove in the respective strut 512 such that barb 534at least partially sits in the groove, thereby restraining barb 534 fromreturning to its pre-set bent configuration. Lips 514 also prevent ring532 from rotating around central longitudinal axis LA until a force isapplied to overcome the restraining force of lips 514, thereby rotatingring 532 and enabling barbs 534 to return to their pre-set bentconfiguration, as explained in more detail below.

Ring 532 may also be restrained from moving longitudinally along outflowportion 520. Ring 532 may be restrained by lips, grooves, or any otherway to prevent ring 532 from sliding longitudinally along outflowportion 520 while still enabling ring 532 to rotate about centrallongitudinal axis LA. In one non-limiting embodiment shown in FIG. 11C,a groove 522 is provided circumferentially around a portion of outflowtube 520. Ring 532 is disposed in groove 522 such ring 532 is disposedbetween a shoulder 524 that prevents longitudinal movement towardssecond (outflow) end 508 and inflow ring 510 that prevents longitudinalmovement toward first (inflow) end 506. In another non-limiting exampleshown in FIG. 11D, a lip 526 may extend radially outward from outflowportion 520 distal of ring 532. Thus, ring 532 is disposed between lip526 and inflow ring 510 such that lip 526 prevents longitudinal movementof ring 532 in a distal (outflow) direction and inflow portion 510prevents longitudinal movement of ring 532 in a proximal (inflow)direction. Lip 526 may be a continuous lip disposed around thecircumference of outflow portion 520, or a plurality of lips 526 may bedisposed intermittently (i.e., spaced from each other) around thecircumference of outflow portion 520.

Torque anchoring mechanism 530 is configured such that a delivery device(an example of which is described below) may interact with torqueanchoring mechanism 530 to rotate ring 532 such that barbs 534 may embedin tissue at the desired implantation site. In the embodiment shown inFIGS. 11A-11D and 12A-12B, ring 532 of torque anchoring mechanism 530includes a plurality of connection points 538 for a delivery system. Inan embodiment, connections points 538 are openings disposed through ring532 for tethers or rods of a delivery system to connect with, asdescribed in more detail below. In the embodiment shown in FIGS.12A-12B, three (3) connection points 538 are shown. However, more orfewer connection points 538 may be utilized provided that the deliverysystem is configured to rotate ring 532 to overcome the restrainingforce of lips 514.

With the above of the components of heart valve prosthesis 500 in mind,delivery and deployment of heart valve prosthesis 500 is explained.Heart valve prosthesis 500 is compressed into the radially compressedconfiguration for delivery. In the radially compressed configuration,outflow tube 520 is radially compressed. Inflow portion 510 and torqueanchor mechanism 530 may be rotated such that they extend longitudinallyaway from outflow portion 520 and may be radially compressed. Heartvalve prosthesis 500 is delivered to the treatment site such as a nativemitral valve in a delivery device in the radially compressedconfiguration. When at the treatment site, a capsule or sheath of thedelivery device may be retracted, thereby enabling heart valveprosthesis 500 to self-expand to the radially expanded configurationshown in FIGS. 11A and 12A. As can be seen in FIGS. 11A and 12A, barbs534 extend radially outward. The delivery system remains coupled toheart valve prosthesis 500, such as through tethers described belowinteracting with connection points 538 of ring 532. With heart valveprosthesis 500 at the desired location and in the radially expandedconfiguration, the delivery device or a portion thereof is rotated suchthat the portion of the delivery device connected to ring 532 isrotated, thereby rotating ring 532. This rotation overcomes theretraining force of lips 514. With barbs 534 no longer restrained bylips 514, barbs 534 revert back to their pre-set bent configuration, asshown in FIG. 12B. Also, due to rotation of ring 532, the now angledbarbs 534 embed into tissue at the implantation site, thereby anchoringheart valve prosthesis 500 at the implantation site.

Although a specific embodiment of heart valve prosthesis 500 has beendisclosed, variations may be made in keeping with the presentdisclosure. For example, and not by way of limitation, barbs 534 neednot be straightened by lips 514 and then returned to their pre-set bentconfiguration. Instead, barbs 534 may be curved or bent prior torotation of ring 532. In such an embodiment, lips 514 may be eliminatedor may still be used to keep ring 534 from rotating during delivery andinitial deployment of heart valve prosthesis 500. In such an embodiment,when heart valve prosthesis is initially deployed from the deliverysystem, heart valve prosthesis 500 radially expands as shown in FIG.12C. As can be seen, barbs 534 are already curved or bent. However, asdescribed above, each barb 534 may be held in place by lips 514. Thus, aportion of each barb 534 in FIG. 12C is hidden by the correspondingstrut 512. As explained above, the delivery system remains coupled toheart valve prosthesis 500 of FIG. 12C, such as through tethersdescribed below interacting with connection points 538 of ring 532. Withheart valve prosthesis 500 at the desired location and in the radiallyexpanded configuration, the delivery device or a portion thereof isrotated such that the portion of the delivery device connected to ring532 is rotated, thereby rotating ring 532. This rotation overcomes theretraining force of lips 514. Thus, ring 532 rotates and angled barbs534 embed into tissue at the implantation site, thereby anchoring heartvalve prosthesis 500 at the implantation site.

Other variations to heart valve prosthesis 500 may be utilized. Forexample, and not by way of limitation, clips or arms at second (outflow)end 208 may be utilized for heart valve prosthesis 500 to engage nativeleaflets of the native valve. Further, elements of the other embodimentsdescribed above and below may be utilized with heart valve prosthesis500.

FIG. 13 shows another embodiment of heart valve prosthesis 310. FIG. 13illustrates heart valve prosthesis 310 in a radially expandedconfiguration. Heart valve prosthesis 310 includes a frame 314 and aprosthetic valve 312 coupled to the frame 314. Heart valve prosthesis310 includes a radially collapsed configuration and the radiallyexpanded configuration. Heart valve prosthesis 310 also includes a firstend 326 and a second end 332 opposite first end 326. Frame 314 isgenerally tubular and defines a central passage 324, and includes afirst end 334 and a second end 336. In the embodiment shown in FIG. 13,first end 334 of frame 314 defines first end 326 of heart valveprosthesis 310. Similarly, second end 336 of frame 314 defines secondend 332 of heart valve prosthesis 310. Those skilled in the art wouldrecognize that other features, such as skirts or arms may be included aspart of heart valve prosthesis 310. In the embodiment shown, first end326 of heart valve prosthesis 310 is the proximal or inflow end, andsecond end 332 of heart valve prosthesis is the distal or outflow end ofheart valve prosthesis 310. Also, first end 334 of frame 314 is flaredradially outwardly, as shown in FIG. 13. This outward flare at first end334 forms an inflow rim 315 that is configured to contact an atrial sideof a native mitr1l valve annulus. Further, although inflow rim 315 isshown as generally circular, inflow rim may be other shapes to conformto the anatomy adjacent the native mitr1l valve, such as but not limitedD-shaped. A portion of frame 314 may also be described as an outflowportion 325. Outflow portion 325 is generally tubular and is configuredto extend through the leaflets of the native valve complex. Althoughheart valve prosthesis 310 as shown is configured for placement at thesite of a native mitr1l valve, heart valve prosthesis 310 may be used atother implantation sites, such as, but not limited to, other the sitesof native heart valves.

Frame 314 is a support structure that comprises struts 316 arrangedrelative to each other with a plurality of open spaces 317 therebetween.Frame 314 provides a desired compressibility and expansion force againsta native annulus at the desired implantation site. Frame 314 alsoprovides support for prosthetic valve 312. Prosthetic valve 312 iscoupled to and disposed within frame 314. Although the embodiment ofFIG. 13 does not show the radially outward portion of inflow rim 315bent to extend longitudinally as in FIG. 1, this is not limiting andheart valve prosthesis 310 of FIG. 13 may include such a bend. Struts316 of inflow rim 315 form a plurality of peaks 318 and valleys 320 at afirst end of inflow rim 315.

A plurality of torque anchoring mechanisms 322 are coupled to inflow rim315. Torque anchoring mechanisms 322 are configured such that when heartvalve prosthesis 310 is in the radially expanded configuration at adesired implantation site, and at least a portion of heart valveprosthesis 310 is rotated, torque anchoring mechanisms 322 are embeddedinto tissue at the desired implantation site. As shown in FIG. 13,torque anchoring mechanisms 322 extend clockwise. However, they mayextend counter-clockwise or partially angled in either direction.Further, torque anchoring mechanisms 322 may generally extend from anunderside 319 of inflow rim 315. The underside 319 of inflow rim 315 isthe surface facing the native mitral valve annulus when the heart valveprosthesis 310 is deployed with inflow rim 315 on the atrial side of thenative mitral valve annulus (i.e., the surface of the inflow rim facingthe outflow end). Torque anchoring mechanisms 322 may be barbs, clips,hooks, arrows or similar devices configured to embed into tissue at thedesired implantation site. While FIG. 13 shows each torque anchoringmechanism 322 as single wire, this is not limiting and otherconfigurations of torque anchoring mechanisms may be used.

Frame 314 may be formed, for example, and not by way of limitation, ofnickel titanium, Nitinol, nickel-cobalt-chromium-molybdenum (MP35N),stainless steel, high spring temper steel, or any other metal orsuitable for purposes of the present disclosure. Torque anchoringmechanisms 322 may be formed from the same types of materials as frame314. Torque anchoring mechanisms 322 may be extensions of struts 316, ormay be coupled to frame 314, for example, and not by way of limitation,by fusing, welding, adhesive, sutures, or other means suitable for thepurposed described herein.

Frame 314 shown in FIG. 13 further includes a plurality of tetherconnection points 338. In the embodiment shown, tether connection points338 are shown at valleys 320, but they may be located elsewhere oninflow rim 315. In the embodiment shown, tether connections points 338are openings that enable a tether of a delivery system to couple withheart valve prosthesis 310, either by direct coupling or looping throughor around, to rotate heart valve prosthesis 310 or a portion thereof toembed torque anchoring mechanisms 322 into tissue at the implantationsite, as described in more detail below.

With the above understanding of heart valve prosthesis 310 in mind, adelivery device 400 shown in FIGS. 14-16 may be used to deliver anddeploy a heart valve prosthesis such as heart valve prosthesis 310. Inan embodiment, delivery device 400 generally includes a handle 440, anouter shaft assembly 410, an inner shaft assembly 404, a tether shaft450, and a plurality of tethers 460. Delivery device 400 may be madefrom any suitable material, such as, but not limited to polyethylene(PE), polyethylene terephthalate (PET), and polyvinylchloride (PVC).Various features of the components of delivery device 400 reflected inFIGS. 14-16 and described below can be modified or replaced withdiffering structures and/or mechanisms. The components of deliverydevice 400 may assume different forms and construction. Therefore, thefollowing detailed description is not meant to be limiting. Further, thesystems and functions described below can be implemented in manydifferent embodiments of hardware. Any actual hardware described is notmeant to be limiting. The operation and behavior of the systems andmethods presented are described with the understanding thatmodifications and variations of the embodiments are possible given thelevel of detail presented.

In an embodiment shown schematically in FIGS. 14-15, handle 440 mayinclude a housing 442 with an actuator mechanism 444 and a rotatormechanism 470 retained therein. More particularly, handle 440 includes acavity 443 defined by housing 442 and configured to receive portions ofactuator mechanism 444 and rotator mechanism 470. In the embodimentshown in FIGS. 14-15, housing 420 forms a longitudinal slot 446 throughwhich actuator mechanism 444 extends for interfacing by a user, and arotational slot 472 through which rotator mechanism 470 extends forinterfacing by a user. Handle 440 provides a surface for convenienthandling and grasping by a user, and may have a generally cylindricalshape, as shown, or other shapes. Actuator mechanism 444 is generallyconstructed to provide selective retraction/advancement of outer shaftassembly 410 and can have a variety of constructions and/or devicescapable of providing the desired user interface. Although shown as aslide mechanism, other constructions and/or devices may be used toretract/advance outer shaft assembly 410, such as, but to limited torotating mechanisms, sliding mechanisms that are coaxially disposed overinner shaft assembly 404, combinations of rotating and slidingmechanisms, and other advancement/retraction mechanisms known to thoseskilled in the art. Similarly, rotator mechanism 470 may be anymechanism used to rotate tethers 460.

Outer shaft assembly 410 is slidably disposed over inner shaft assembly404. With reference to FIGS. 14-15, in an embodiment, outer shaftassembly 410 includes a proximal shaft 418 and a capsule 407, anddefines a lumen 412 extending from a proximal end 430 of proximal shaft418 to a distal end 432 of capsule 407. Although outer shaft assembly410 is described herein as including capsule 407 and proximal shaft 418,capsule 407 may simply be an extension of proximal shaft 418. Further,outer shaft assembly 410 may be referred to as a sheath or outer sheath.Proximal shaft 418 is configured for connection to capsule 407 at aconnection point 416 at a proximal end 409 of capsule 407 by fusing,welding, adhesive, sutures, or other means suitable for the purposesdescribed herein. Alternatively, proximal shaft 418 and capsule 407 maybe unitary. Proximal shaft 418 extends proximally from capsule 407 andis configured for connection to handle 440. More particularly, proximalshaft 418 extends proximally into housing 442 of handle 440 and aproximal portion 431 of proximal shaft 418 is connected to actuatormechanism 444 of handle 440. Proximal portion 431 is coupled to actuatormechanism 444 such that movement of actuator mechanism 444 causes outershaft assembly 410 to move relative inner shaft assembly 404. Proximalshaft 418 may be coupled to actuator mechanism 444, for example, and notby way of limitation, by adhesives, welding, clamping, and othercoupling devices as appropriate. Outer shaft assembly 410 is thusmovable relative to handle 440 and inner shaft assembly 404 by actuatormechanism 444. However, if actuator mechanism 444 is not moved andhandle 440 is moved, outer shaft assembly 410 moves with handle 440, notrelative to handle 440.

Inner shaft assembly 404 is similar to inner shaft assembly 104previously described. Inner shaft assembly 404 extends within a lumen456 of tether shaft 450, described in greater detail below and as shownin FIGS. 14-15. Inner shaft assembly 404 includes an inner shaft 414 anda distal tip 422. Inner shaft 414 extends from a proximal end 434 ofinner shaft 414 to a distal end 436 of inner shaft 414. Distal end 436of inner shaft 414 is attached to distal tip 422. The components ofinner shaft assembly 404 combine to define continuous guidewire lumen423, which is sized to receive an auxiliary component such as aguidewire (not shown). Although inner shaft assembly 404 is describedherein as including inner shaft 414 and distal tip 422, distal tip 422may simply be an extension of inner shaft 414. Further, inner shaft maybe several pieces attached together rather than a single piece. Innershaft 414 extends proximally into housing 442 of handle 440, and isconnected to handle 440 such that guidewire lumen 423 provides accessfor auxiliary components (e.g., a guidewire) therein. Inner shaft 414may be coupled to handle 440, for example, and not by way of limitation,by adhesives, welding, clamping, and other coupling devices asappropriate. During sliding or longitudinal movement of outer shaftassembly 410, inner shaft assembly 404 is fixed relative to handle 440.However, in other embodiments, inner shaft assembly may be configured tomove relative to handle 440, such as by another actuator mechanism.

In an embodiment, tether shaft 450 may be coaxially disposed betweeninner shaft 404 and outer shaft assembly 410. Tether shaft 450 may berotated relative to inner shaft assembly 404 and outer shaft assembly410. With reference to FIGS. 14-15, tether shaft 450 includes a proximalshaft portion 466 and a distal shaft portion 468, and defines lumen 456extending from a proximal end 452 to a distal end 454 of tether shaft450. Proximal shaft portion 466 is configured for connection to handle440. Proximal shaft portion 466 of tether shaft 450 extends proximallyinto housing 442 of handle 440 and is connected to rotator mechanism 470of handle 440. Proximal shaft portion 466 is coupled to rotatormechanism 470 such that movement of rotator mechanism 470 causes tethershaft 450 to rotate about a central longitudinal axis LA_(c) relative toouter shaft assembly 410 and inner shaft assembly 404. Proximal shaftportion 466 may be coupled to rotator mechanism 470, for example, andnot by way of limitation by adhesives, welding, clamping, and othercoupling devices as appropriate. Tether shaft 450 is thus rotationallymovable relative to housing 442, inner shaft assembly 404, and outershaft assembly 410 by rotator mechanism 470. However, if rotatormechanism 470 is not moved and housing 442 is moved, tether shaft 450moves with housing 442, not relative to housing 442. A plurality oftether connection points 458 are located at distal shaft portion 468 oftether shaft 450, proximal of distal end 464. Tether connection points458 are configured to couple distal shaft portion 468 of tether shaft450 to tethers 460 as described below. While FIG. 16 shows tetherconnection points 458 arranged circumferentially around tether shaft450, this is not meant to limit the design and other configurations arecontemplating based upon the application. Non-limiting examples of theconnection of tethers 460 to tether connection points 458 includeconfigurations releasable by manipulation of the outer shaft 410 such asretainer posts and knot/ball retention apertures, configurationsreleasable by severing/cutting the tether, and other configurationssuitable for the purposes described herein.

In an embodiment, tethers 460 includes a first end 462 coupled to arespective tether connection point 338 of heart valve prosthesis 310,and a second end 464 coupled to tether connection points 458 of tethershaft 450, as shown in FIG. 15.

Tethers 460 are elongated members such as wires. Tethers 460 arerelatively rigid such that rotation of tethers 460 increases tautness oftethers 460 such that when taut, rotational torque applied to tethers460 is transmitted to heart valve prosthesis 310 to rotate heart valveprosthesis 310. Tethers 460 may be connected to tether shaft 450 bymethods such as, but not limited to fusing, welding, or mechanicalconnections. Alternatively, tethers 460 may extend through tether shaft450 to driver mechanisms (not shown), such as but not limited tosliders, buttons, knobs, and similar mechanisms, to rotate tethers 460and to release tethers 460 from heart valve prosthesis 310. Tethers 460may be releasably connected to connection points 338 and tetherconnection points 458 in any manner suitable for the purpose herein;namely, a sufficiently rigid connection such that rotation of tethers460 is transmitted to heart valve prosthesis 310 and a removableconnection. In an alternative embodiment, first ends 462 of tethers 460may be coupled to a respective tether connection points 458 of tethershaft 450, and second ends 464 of tethers 460 are releasably coupled tocorresponding tether connection points 458 of tether shaft 450. In anembodiment, a portion of each tether 460 is looped through open spaces17 and around struts 16 of frame 14 at corresponding tether connectionpoints 338.

With the above understanding of components in mind, operation andinteraction of components of the present disclosure may be explainedherein. As shown in FIG. 15, heart valve prosthesis 310 is disposed in aradially compressed configuration within capsule 407 of outer shaftassembly 410. In this delivery configuration, tethers 460 are coupled toheart valve prosthesis 310 and connection points 338. Delivery device400 is delivered to an implantation site, such as the site of a nativemitral valve. When at the implantation site, outer shaft assembly 410 isretracted proximally, thereby retracting capsule 407 proximally. Capsule407 is retracted proximally sufficient to expose heart valve prosthesis310. In the embodiment shown, heart valve prosthesis 310 isself-expanding. Therefore, retraction of capsule 407 enables heart valveprosthesis 310 to self-expand to the radially expanded configuration, asshown in FIG. 16. User actuation of rotator mechanism 470 in directionR_(r) relative to central longitudinal axis LA_(c) rotates tether shaft450 in direction R_(r) such that tethers 460 are rotated in directionR_(r). Rotation of tethers 460 imparts a rotational force in directionR_(r) on inflow rim 315 of heart valve prosthesis 310 such that at leasta portion of heart valve prosthesis 310 rotates in direction R_(r) suchthat torque anchoring mechanisms 322 are embedded in tissue at thedesired implantation site. Stated another way, with heart valveprosthesis 310 in the radially expanded configuration at the desiredimplantation site, tethers 460 are rotated in direction R_(r) to embedanchoring mechanisms 322 in tissue, thereby anchoring heart valveprosthesis 310 at the desired implantation site. In an alternativeembodiment, tethers 460 are looped through heart valve prosthesis 310around connection points 338. Once heart valve prosthesis 310 isanchored, outer shaft 410 is retracted further proximally, releasing thesecond ends 464 of tethers 460 from tether shaft 450 such that tethers460 may be removed with delivery device 400. In other embodiments,tethers 460 may be released from tether shaft 450 and remain with heartvalve prosthesis 310. In yet another embodiment, tethers 460 may besevered and a portion coupled to tether shaft 450 removed with deliverydevice 400 and a portion coupled to heart valve prosthesis 310 remainingwith heart valve prosthesis 310.

FIGS. 17-19 illustrate another embodiment of delivery device 400′ fordelivering and deploying a heart valve prosthesis 10. Delivery device400′ is similar to the embodiment of FIGS. 14-16, so only thedifferences between the embodiments will be described in detail here.Features not specifically described may be like those described withrespect to the embodiment of FIGS. 14-16, or other embodiments describedherein. In the embodiment of FIGS. 17-19, instead of a tether shaft 450and tethers 460, as described above, delivery device 400′ includes a rodshaft 450′ and rods 460′.

In an embodiment, rod shaft 450′ may be coaxially disposed between innershaft 404 and outer shaft assembly 410. Rod shaft 450′ may be rotatedrelative to inner shaft assembly 404 and outer shaft assembly 410. Withreference to FIGS. 17-18, rod shaft 450′ includes a proximal shaftportion 466′ and a distal shaft portion 468′, and defines a lumen 456′extending from a proximal end 452′ to a distal end 454′ of rod shaft450′. Proximal shaft portion 466′ is configured for connection to handle440. Proximal shaft portion 466 of rod shaft 450′ extends proximallyinto housing 442 of handle 440 and is connected to rotator mechanism 470of handle 440. Proximal shaft portion 466′ is coupled to rotatormechanism 470 such that movement of rotator mechanism 470 causes rodshaft 450′ to rotate about a central longitudinal axis LA, relative toouter shaft assembly 410 and inner shaft assembly 404. Proximal shaftportion 466′ may be coupled to rotator mechanism 470, for example, andnot by way of limitation by adhesives, welding, clamping, and othercoupling devices as appropriate. Rod shaft 450′ is thus rotationallymovable relative to housing 442, inner shaft assembly 404, and outershaft assembly 410 by rotator mechanism 470. However, if rotatormechanism 470 is not moved and housing 442 is moved, rod shaft 450′moves with housing 442, not relative to housing 442. A plurality of rodconnection points 458′ are located at distal shaft portion 468 of rodshaft 450′. Rod connection points 458′ are configured to pivotablycouple distal shaft portion 468′ of rod shaft 450′ to rods 460′ asdescribed below. While FIG. 19 shows rod connection points 458′ arrangedcircumferentially around rod shaft 450′, this is not meant to limit thedesign and other configurations are contemplating based upon theapplication.

In an embodiment, each rod 460′ includes an atraumatic first end 462′and a second end 464′. Each second end 464′ is pivotably coupled to acorresponding rod connection point 458′ of rod shaft 450′, as shown inFIG. 17. Rods 460′ are elongated rigid members such as wires. Rods 460′include a pivotably collapsed configuration when disposed within outershaft assembly 410, and a pivotably expanded configuration with firstends 462′ radially expanded outward from inner shaft 414, and secondends 464′ pivotably coupled to rod shaft 450′, as shown in FIG. 19. Rods460′ are self-expanding in that they remain in the pivotably expandedconfiguration unless compressed to the pivotably collapsed configurationwhen retained within capsule 407 and outer shaft 410. When in thepivotably expanded configuration, first ends 462′ are radially expandedto a first diameter D1. First diameter D1 is equal to the diameter ofconnection points 338′ such that advancement distally of delivery device400′ selectively couples first ends 462′ with connection points 338′ ona torque portion 350 of heart valve prosthesis 310. First ends 462′ willremain selectively coupled with connection points 338′ with continueddistal force on delivery device 400′. When selectively coupled, rotationof rod shaft 450′ and pivotably coupled rods 460′ is transmitted toheart valve prosthesis 310 to rotate heart valve prosthesis 310. Rods460′ may be pivotably connected to rod shaft 450′ by methods such as,but not limited to fusing, welding, flex-joint, or mechanisms suitablefor the purposes described herein. Rods 460′ may be selectively coupledto connection points 338′ by various methods such as, but not limited torod-cup mechanisms, rod-slot mechanisms, friction-fit mechanisms, orother methods suitable for the purposes described herein.

With the above understanding of components in mind, operation andinteraction of components of the present disclosure may be explainedherein. As shown in FIG. 18, heart valve prosthesis 310 is disposed in aradially compressed configuration within capsule 407 of outer shaftassembly 410. In this delivery configuration, rods 460′ are retained inthe pivotably collapsed configuration within capsule 407 and outer shaft410 with first ends 462, selectively coupled to heart valve prosthesis310 at rod connection points 338′. Delivery device 400′ is delivered toan implantation site, such as the site of a native mitral valve. When atthe implantation site, outer shaft assembly 410 is retracted proximally,thereby retracting capsule 407 proximally. Capsule 407 is retractedproximally sufficient to expose heart valve prosthesis 310. In theembodiment shown, heart valve prosthesis 310 is self-expanding.Therefore, retraction of capsule 407 enables heart valve prosthesis 310to self-expand to the radially expanded configuration. Once heart valveprosthesis is in the radially expanded configuration, outer shaftassembly 410 is retracted further proximally, thereby retracting capsule407 proximally. Capsule 407 is retracted proximally sufficient to exposerods 460′. In the embodiment shown, rods 460′ are self-expanding.Therefore, retraction of capsule 407 enables rods 460′ to self-expand tothe pivotably expanded configuration, as shown in FIG. 19. With rods460′ in the pivotably expanded configuration, delivery device 400′ isadvanced distally until each first end 462′ is selectively coupled witha corresponding connection point 338′ of heart valve prosthesis 310.Once selectively coupled by distal force on delivery device 400′ useractuation of rotator mechanism 470 in direction R_(r) relative tocentral longitudinal axis LA_(c) rotates rod shaft 450′ in directionR_(r) such that rods 460′ are rotated in direction R_(r). Rotation ofrods 460′ imparts a rotational force in direction R_(r) heart valveprosthesis 310 such that at least a portion of heart valve prosthesis310 rotates in direction R_(r) such that torque anchoring mechanisms 322are embedded in tissue at the desired implantation site. Once heartvalve prosthesis 310 is anchored, delivery device 400′ is retractedproximally such that rods 460′ are selectively uncoupled form connectionpoints 338′. When rods 460′ are selectively uncoupled form connectionpoints 338, outer shaft assembly 410 is advanced distally, therebyadvancing capsule 407 distally. Capsule 407 is advanced distallysufficient to radially compress rods 460′ to the pivotably collapsedconfiguration. Delivery device 400′ may be then be retracted proximallyfor removal from the implantation site. While rod shaft 450′ and rods460′ are described herein as part of delivery device 400′, this is notmeant to limit the design, and in other embodiments, rod shaft 450′ androds 460′ may be a separate device advanced to the implantation sitefollowing the expansion of heart valve prosthesis 310 and removal ofdelivery device 400′.

Features of any of the embodiments described above may be used with anyof the other embodiments described above. Further, variations in thenumber and types of tethers, rods, shafts, actuating mechanisms, andsimilar items may be made within the scope of the invention. Othermaterials than those described above may also be used within the scopeof the invention.

A method of deploying and anchoring a heart valve prosthesis at adesired implantation site with a delivery device in accordance with anembodiment hereof is schematically represented in FIGS. 20-24. Themethod steps of FIGS. 20-24 are described with respect to deliverydevice 100′″ including dumbbell-shaped balloon 170. However, thisembodiment may be used with other delivery devices described herein.Using established percutaneous transcatheter delivery procedures,delivery device 100′″ is introduced into a patient's vasculature,advanced over a guidewire, and positioned at a treatment site of adamaged or diseased native valve, which in this embodiment is a nativemitral valve 730 of a heart 700, as shown in FIG. 20.

With delivery device 100′″ in place, actuator mechanism 144 of handle140 is operated proximally to outer shaft assembly 110. As capsule 107of outer shaft assembly 110 is retracted proximally, heart valveprosthesis 10 transitions from the radially collapsed configuration tothe radially expanded configuration, as shown in FIG. 21.

Once heart valve prosthesis 10 is in the radially expandedconfiguration, inflation fluid is injected into dumbbell-shaped balloon170 such that dumbbell-shaped balloon 170 transitions from theuninflated configuration to the inflated configuration as shown in FIG.22. Balloon 170 is configured such that when in the inflatedconfiguration, shaped end 174 of first portion 172 of dumbbell-shapedballoon 170 engages corresponding shaped end 26 of heart valveprosthesis 10, proximal end 182 of second portion 180 of dumbbell-shapedballoon 170 abuts proximal end 34 of heart valve prosthesis 10, andouter surface 189 (not shown in FIGS. 20-24) of third portion 186 ofdumbbell-shaped balloon 170 engages the inner surface of frame 14 ofheart valve prosthesis 10.

Next, delivery device 100′″ is rotated in direction R_(r) about centrallongitudinal axis LA_(c). Rotation of delivery device 100′″ in directionR_(r) about central longitudinal axis LA_(c), rotates dumbbell-shapedballoon 170 in direction R_(r), which rotates at least a portion ofheart valve prosthesis 10 in direction R_(r), and torque anchoringmechanism 22 is embedded into tissue at the desired implantation site,as shown in FIG. 23.

Next, inflation fluid is drained from dumbbell-shaped balloon 170 suchthat dumbbell-shaped balloon 170 transitions from the inflatedconfiguration to the first uninflated configuration. Delivery device100′″ is retracted through patient's vasculature, leaving heart valveprosthesis 10 anchored in at the site of the native mitral valve, asshown in FIG. 24.

The method described with respect to FIGS. 20-24 may be used with otherdevices and features described herein. Further, variations, additionalsteps, and fewer steps may be utilized as would be understood by thoseskilled in the art.

Another method of deploying and anchoring a heart valve prosthesis at adesire implantation site with a delivery device in accordance with anembodiment hereof is schematically represented in FIGS. 25-29. Themethod steps of FIGS. 25-29 are described with respect to deliverydevice 400 and heart valve prosthesis 310 described previously. Usingestablished percutaneous transcatheter delivery procedures, deliverydevice 400 is introduced into a patient's vasculature, advanced over aguidewire, and positioned at a treatment site of a damaged or diseasednative valve, which in this embodiment is native mitral valve 730 ofheart 700, as shown in FIG. 25.

Actuator mechanism 444 of handle 440 is operated proximally to retractouter shaft assembly 410. As capsule 407 of outer shaft assembly 410 isretracted proximally, heart valve prosthesis 310 transitions from theradially collapsed configuration to the radially expanded as shown inFIG. 26.

With heart valve prosthesis 310 in the radially expanded configuration,shown in FIG. 27, rotator mechanism 470 of handle 440 is rotated indirection R_(r) about central longitudinal axis LA_(c). Rotation ofrotator mechanism 470 causes tether shaft 450 and tethers 460 attachedthereto to rotate in direction R_(r). Rotation tethers 460 causes leasta portion of heart valve prosthesis 310 to rotate in direction R_(r),thereby embedding torque anchoring mechanisms 322 of heart valveprosthesis 310 into tissue at the desired implantation site, as shown inFIG. 28.

Tethers 460 may then be released from heart valve prosthesis 310, asdescribed above. Delivery device 400 may then be removed from thepatient, leaving heart valve prosthesis 310 anchored in heart 700, asshown in FIG. 29.

The method described with respect to FIGS. 25-29 may be used with otherdevices and features described herein. Further, variations, additionalsteps, and fewer steps may be utilized as would be understood by thoseskilled in the art. For example, and not by way of limitation, deliverydevice 400 may be used with the heart valve prosthesis described withrespect to FIGS. 10A-11D above, or the heart valve prostheses describedwith respect to FIGS. 35, below.

Another method of deploying and anchoring a heart valve prosthesis at adesire implantation site with a delivery device in accordance with anembodiment hereof is schematically represented in FIGS. 30-34. Themethod steps of FIGS. 30-34 are described with respect to deliverydevice 400′ and heart valve prosthesis 310 described previously. Usingestablished percutaneous transcatheter delivery procedures, deliverydevice 400′ is introduced into a patient's vasculature, advanced over aguidewire, and positioned at a treatment site of a damaged or diseasednative valve, which in this embodiment is native mitral valve 730 ofheart 700, as shown in FIG. 30.

Actuator mechanism 444 of handle 440 is operated proximally to retractouter shaft assembly 410. As capsule 407 of outer shaft assembly 410 isretracted proximally, heart valve prosthesis 310 transitions from theradially collapsed configuration to the radially expanded configuration.With the heart valve prosthesis 310 in the radially expandedconfiguration, delivery device 400′ is advanced distally. Actuatormechanism 444 of handle 440 is operated proximally to retract outershaft assembly 410. As capsule 407 of outer shaft assembly 410 isretracted proximally, rods 460′ of rod shaft 450′ transition from thepivotably collapsed configuration to the pivotably expandedconfiguration. Delivery device 400′ is advanced distally and rods 460′engage connection points 338′ of heart valve prosthesis 310, as shown inFIG. 31.

With heart valve prosthesis 310 in the radially expanded configuration,shown in FIG. 32 and rods 460′ engaged thereto, rotator mechanism 470 ofhandle 440 is rotated in direction R_(r) about central longitudinal axisLA_(c). Rotation of rotator mechanism 470 causes rod shaft 450′ and rods460′ attached thereto to rotate in direction R_(r). Rotation of rods460′ causes at least a portion of heart valve prosthesis 310 to rotatein direction R_(r), thereby embedding torque anchoring mechanisms 322 ofheart valve prosthesis 310 into tissue at the desired implantation site,as shown in FIG. 33.

Delivery device 400′ may then be retracted proximally such that rods460′ disengage and are released from connection points 338′ of heartvalve prosthesis 310. Outer shaft 410 (including capsule 407) isadvanced distally and rods 460′ radially compress from the pivotablyexpanded configuration to the pivotably collapsed configuration.Delivery device 400′ may then be removed from the patient, leaving heartvalve prosthesis 310 anchored in heart 700, as shown in FIG. 34.

The method described with respect to FIGS. 30-34 may be used with otherdevices and features described herein. Further, variations, additionalsteps, and fewer steps may be utilized as would be understood by thoseskilled in the art.

FIGS. 35-36 schematically show another embodiment of a heart valveprosthesis 600. Heart valve prosthesis 600 is similar to the heart valveprostheses described above, and thus will not be described in detail.Heart valve prosthesis 600 includes a frame 614 and a prosthetic valve612. Frame 614 defines a central passage 624 in which prosthetic valve612 is disposed. Frame 614 also defines an inflow rim 615 and an outflowtube 625. Inflow rim 615 includes a plurality of torque anchoringmechanisms 622 coupled thereto, as described above. Heart valveprosthesis 600 also includes a plurality of arms 650 coupled to outflowtube 625. Arms 650 are shown folded back such that arms 650 are disposedoutside of an outer surface of outflow tube 625. Each arm 650 may beconfigured to capture a native leaflet of a native valve between the armand the outer surface of outflow tube 625. Arms 650 may extendinglongitudinally away from the outflow end of outflow tube 625 when in theradially compressed delivery configuration, and then fold back into theposition shown in FIG. 35 when radially expanded. Using a heart valveprosthesis with arms 650 to capture the native leaflets between the arms650 and outflow tube 625, it is not desirable to rotate such a heartvalve prosthesis to embed torque anchoring mechanisms 622 into tissueadjacent the native valve because such toque is transferred to arms 650and the native valve leaflets.

Thus, in the embodiment shown in FIG. 35, inflow rim 615 is decoupledfrom outflow tube 625. By “decoupled”, it is meant that inflow rim 615may be rotated at least partially without rotating outflow tube 625. Inthe embodiment shown in FIG. 35, inflow rim 615 is decoupled fromoutflow tube 625 using a joint 640. Joint 640 may be a flexible materialsuch as, but not limited to a fabric material (e.g., polyester, nylon,etc.) A first end 642 of joint 640 is attached to inflow rim 615 and asecond end 644 of joint 640 is attached to outflow tube 625. Joint 640may be coupled to inflow rim 615 and outflow tube 625 by sutures,adhesives, and other connections suitable for the purposes describedherein. Using heart valve prosthesis 600 with joint 640, after heartvalve prosthesis is radially expanded at the treatment site with thenative valve leaflets captured between arms 650 and outflow tube 625,inflow rim 615 may be rotated to embed torque anchoring mechanisms 622without rotating outflow tube 625. Instead, joint 640 twists to absorbthe rotation of inflow rim 615. Inflow rim 615 may be rotated by any ofthe devices and methods described above.

In another embodiment, instead of joint 640 being a flexible material,inflow rim 615 and outflow tube 625 may be connected to each other in amanner that permits relative rotation there between, but does not permitlongitudinal separation. FIG. 36 shows an example of such a joint 670.In the embodiment shown, inflow rim 615 includes a tubular portion 680extending towards outflow tube 625. An end of tubular portion 680opposite inflow rim 615 includes a lip 574. Outflow tube 625 includes anend opposite the outflow end with a groove 672. Lip 672 is disposed ingroove 674. Such a connection enables inflow rim 615 to rotate relativeto outflow tube 625 while keeping inflow rim 615 and outflow tube 625coupled to each other.

Using heart valve prosthesis 600 with joint 670, after heart valveprosthesis is radially expanded at the treatment site with the nativevalve leaflets captured between arms 650 and outflow tube 625, inflowrim 615 may be rotated to embed torque anchoring mechanisms 622 withoutrotating outflow tube 625. Inflow rim 615 may be rotated by any of thedevices and methods described above.

While only some embodiments have been described herein, it should beunderstood that it has been presented by way of illustration and exampleonly, and not limitation. Various changes in form and detail can be madetherein without departing from the spirit and scope of the invention,and each feature of the embodiment discussed herein, and of eachreference cited herein, can be used in combination with the features ofany other embodiment. Further, features of any of the embodimentsdescribed herein may be used with any of the other embodiments describedherein. All patents and publications discussed herein are incorporatedby reference herein in their entirety.

What is claimed is:
 1. A delivery device for delivery and deployment ofa heart valve prosthesis having a torque anchoring mechanism, thedelivery device comprising: a balloon having a first uninflatedconfiguration and a second inflated configuration, wherein the balloonincludes a shaped surface configured to engage a corresponding shapedsurface of the heart valve prosthesis, wherein the balloon is configuredto rotate about a central longitudinal axis of the delivery device suchthat the corresponding shaped surface of the heart valve prosthesis isrotated.
 2. The delivery device of claim 1, wherein the balloon is acompliant high friction balloon.
 3. The delivery device of claim 1,wherein an outer surface of the balloon includes a three-dimensionalpattern such that when the balloon is in the second configuration,engagement of the balloon with the heart valve prosthesis is greaterthan engagement of the balloon with the heart valve prosthesis withoutthe three-dimensional pattern on the outer surface of the balloon. 4.The delivery device of claim 1, wherein the shaped surface of theballoon is a distal end of the balloon and is configured to engage acorresponding shaped proximal end of the heart valve prosthesis.
 5. Thedelivery device of claim 1, wherein the shaped surface of the ballooncomprises a plurality of peaks and valleys that are configured to engagewith a plurality of corresponding valleys and peaks of the correspondingshaped surface of the heart valve prosthesis.
 6. The delivery device ofclaim 1, further comprising a second balloon configured to abut a secondend of the heart valve prosthesis opposite the shaped surface of theheart valve prosthesis.
 7. The delivery device of claim 1, wherein theballoon comprises a dumbbell-shaped balloon, wherein the dumbbell-shapedballoon, in the second inflated configuration includes a first portionhaving a first expanded diameter, a second portion having a secondexpanded diameter, and a third portion disposed between the firstportion and the second portion and having a third expanded diameter,wherein the third expanded diameter is smaller than both the firstexpanded diameter and the second expanded diameter, wherein the shapedsurface of the balloon comprises a shaped end of the first portion. 8.The delivery device of claim 7, wherein the shaped end of the firstportion of the dumbbell-shaped balloon is a distal end of the firstportion and is configured to engage a proximal end of the heart valveprosthesis, and wherein the second portion of the dumbbell-shapedballoon is configured to abut a distal end of the heart valveprosthesis.
 9. A delivery device for delivery and deployment of a heartvalve prosthesis having a torque anchoring mechanism, the deliverydevice comprising: an inner shaft; a torqueing shaft disposed above theinner shaft, wherein the torqueing shaft includes a proximal shaftportion and a plurality of members extending from a distal portion ofthe proximal shaft portion of the torqueing shaft, wherein the pluralityof members are configured to engage an end of the heart valveprosthesis, and wherein the torqueing shaft is rotatable about the innershaft such that rotation of the torqueing shaft correspondingly rotatesthe members and at least a portion of the heart valve prosthesis. 10.The delivery device of claim 9, wherein the torqueing shaft is a tethershaft and the plurality of members are a plurality of tethers.
 11. Thedelivery device of claim 9, wherein the torqueing shaft is a rod shaftand the plurality of members are a plurality of rods.
 12. A method fordeploying and anchoring a heart valve prosthesis at a desiredimplantation site, the method comprising the steps of: delivering theheart valve prosthesis in a radially compressed configuration in adelivery device to a desired implantation site, wherein the heart valveprosthesis includes a torque anchoring mechanism; expanding the heartvalve prosthesis to a radially expanded configuration; and rotating atleast a portion of the heart valve prosthesis to embed the torqueanchoring mechanism into tissue at the desire implantation site.
 13. Themethod of claim 12, wherein the step of expanding the heart valveprosthesis comprises retracting a capsule that maintains the heart valveprosthesis in the radially compressed configuration, thereby exposingthe heart valve prosthesis and enabling the heart valve prosthesis toself-expand.
 14. The method of claim 12, wherein the delivery devicefurther includes a balloon with a shaped end engaged with acorresponding shaped end of the heart valve prosthesis, wherein the stepof rotating at least the portion of the heart valve prosthesis comprisesrotating the balloon such that the shaped end of the balloon rotates thecorresponding shaped end of the heart valve prosthesis.
 15. The methodof claim 12, wherein the delivery device further includes adumbbell-shaped balloon including a first portion, a second portion, anda third portion disposed between the first portion and the secondportion, wherein with the dumbbell-shaped balloon in a second inflatedconfiguration, the first and second portions have expanded diameterslarger than an expanded diameter of the third portion, and wherein thefirst portion includes the shaped end engaged with the correspondingshaped end of the heart valve prosthesis and the second portion abuts anend of the heart valve prosthesis opposite the shaped end of the heartvalve prosthesis, wherein the step of rotating at least the portion ofthe heart valve prosthesis comprises rotating the balloon such that theshaped end of the first portion rotates the corresponding shaped end ofthe heart valve prosthesis.
 16. The method of claim 12, wherein thedelivery device further includes a tether shaft and tethers extendingfrom a distal portion of the tether shaft, wherein the tethers areengaged with the heart valve prosthesis, and wherein the step ofrotating at least the portion of the heart valve prosthesis comprisesrotating the tether shaft such that the tethers rotate the portion ofthe heart valve prosthesis.
 17. The method of claim 12, wherein thedelivery device further includes a rod shaft and rods extending from adistal portion of the rod shaft, wherein the rods are engaged with theheart valve prosthesis, and wherein the step of rotating at least theportion of the heart valve prosthesis comprises rotating the rod shaftsuch that the rods rotate the portion of the heart valve prosthesis.